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FDA 510(k)

AMR RESEARCH TONOMETER

K-Number: K862958 · 1986-11-24

ApplicantAssociated Medical Representatives
Decision Date1986-11-24
Product CodeLCH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMR RESEARCH TONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Associated Medical Representatives. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K862958. The device is classified under product code LCH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMR RESEARCH TONOMETER?

AMR RESEARCH TONOMETER is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Associated Medical Representatives. The 510(k) number is K862958.

When did AMR RESEARCH TONOMETER receive FDA 510(k) clearance?

AMR RESEARCH TONOMETER received FDA 510(k) clearance on 1986-11-24, under 510(k) number K862958.

Who is the listed applicant for AMR RESEARCH TONOMETER?

The FDA 510(k) record lists Associated Medical Representatives as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMR RESEARCH TONOMETER?

The FDA product code for AMR RESEARCH TONOMETER is LCH.

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Related Devices (Code: LCH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K922386RNA MEDICAL TONOMETERBionostics, Inc.K904163CLINICAL BLOOD GAS MIXTURESNorco, Inc.K900819BLOOD GAS CALIBRATION STANDARDCryogenic Rare Gas Laboratories, Inc.K841089LINEAR CLOUD TONOMETERLinear Tonometers, Inc.K802379HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZERAmerican Instrument Co.K801599CORNING 184 BLOOD GAS TONOMETERCorning Medical & Scientific

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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